MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12; QEW

Catalog Number	LITNG12XTORQ100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemoptysis (1887); Great Vessel Perforation (2152)
Date of Event	01/08/2024
Type of Reportable Event	Death
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right pulmonary artery using an indigo system cat12 aspiration catheter (cat12), a penumbra engine (engine), and a non-penumbra sheath.During the procedure, the physician gained access to the target location via the internal jugular vein.The lower right lobe was treated with the cat12.The physician then advanced the cat12 into the upper lobe.The physician was torquing the catheter causing the cat12 to suddenly jump forward and then the patient started to cough blood.It was reported that the torquing of the cat12 may have caused a perforation in the upper lobe.The cat12 was removed and the patient was made to sit upright.It was reported the sheath was inadvertently pulled from the access site in the patient¿s neck when the patient sat up.The sheath was completely removed after the physician had the patient sit upright.Manual pressure was applied to the access site.The patient continued coughing blood and, subsequently, became unresponsive.Later, the patient expired.
Additional Manufacturer Narrative
The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Perforation, hemoptysis, and death are included as possible complications in the instructions for use (ifu) for the indigo aspiration system.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: INDIGO SYSTEM LIGHTNING 12
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 18636334
• Report Number: 3005168196-2024-00035
• Device Sequence Number: 7954762
• Product Code: QEW
• UDI-Device Identifier: 00815948022560
• UDI-Public: 815948022560
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K210323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/02/2024
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2026
• Device Catalogue Number: LITNG12XTORQ100
• Device Lot Number: H00002281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 79 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005